Humacyte, Inc. - HUMA STOCK NEWS

Humacyte, Inc. (HUMA) reported significant advancements in its Human Acellular Vessel (HAV) for vascular treatments, with nearly 500 patients implanted and over 1,000 patient-years of follow-up. The HAV, designed to be durable and infection-resistant, is being evaluated in late-stage trials for arteriovenous access, peripheral arterial disease, and vascular trauma. Recent publications in JAMA Surgery and Annals of Vascular Surgery highlight its innovative nature and clinical efficacy, showcasing no infections or failures thus far. The HAV remains an investigational product and is not FDA-approved yet.

Humacyte, Inc. (Nasdaq: HUMA) has appointed Diane Seimetz, Ph.D., to its board of directors. Dr. Seimetz brings over 22 years of international drug development experience, including her role as co-founder and CEO of Biopharma Excellence. The board chair, Kathleen Sebelius, emphasizes that her expertise will be crucial as Humacyte moves towards the commercialization of its Human Acellular Vessel (HAV). The HAV, currently in late-stage clinical trials for various vascular applications, has received FDA's Regenerative Medicine Advanced Therapy and Fast Track designations.

Humacyte, Inc. (Nasdaq: HUMA) announced the successful implantation of two Human Acellular Vessels (HAV) in wounded Ukrainian patients as part of its humanitarian initiative. The HAVs were provided to aid in treating vascular trauma injuries, showcasing their durability and infection resistance. The cases of the patients, one with shrapnel and the other with a gunshot wound, contribute to real-world evidence supporting HAV treatment. As a priority designation by the U.S. Secretary of Defense, HAVs are currently under evaluation in a Phase 2/3 trial for vascular trauma.

Humacyte, Inc. (Nasdaq: HUMA) presented data at the American Transplant Congress 2022 indicating that its investigational Human Acellular Vessel (HAV) does not increase calculated panel reactive antibodies (cPRA), a key measure linked to transplant rejection risk. The collected data from over 500 patient-years show no evidence of PRA sensitization in more than 470 patients implanted with the HAV. This suggests improved patient outcomes and validates the HAV's potential as a durable, non-immunogenic option for vascular repair. The HAV is currently in late-stage clinical trials.

Humacyte, Inc. (Nasdaq: HUMA) announced that Dale Sander, CFO, and Heather Prichard, COO, will present at the H.C. Wainwright Global Investment Conference on May 24, 2022, at 10:30 a.m. ET in Miami. The conference will be available both in-person and virtually. Humacyte is a clinical-stage biotechnology company focused on developing bioengineered human tissues for medical applications. Their product, human acellular vessels (HAVs), is in late-stage clinical trials and has received FDA designations for vascular trauma and hemodialysis access.

Humacyte announced Q1 2022 financial results and recent achievements, including shipping Human Acellular Vessels (HAVs) to six hospitals in Ukraine for treating vascular trauma, amidst ongoing humanitarian efforts. Newly appointed Chief Medical Officer Shamik Parikh will lead clinical development. Financial highlights show a revenue increase to $233,000, with a net loss of $19.8 million, slightly down from $20.3 million in Q1 2021. The company has cash reserves of $206.2 million, sufficient to fund operations through 2024, supporting their plans for HAV market entry.

Humacyte, Inc. (Nasdaq: HUMA) has initiated the shipment of Human Acellular Vessels (HAVs) to six hospitals in Ukraine, addressing vascular injuries in civilians and soldiers. This initiative follows a request from Ukrainian surgeons and involves coordination with the FDA and Ukraine's Ministry of Health. The HAV is under evaluation in Phase 2/3 trials for vascular trauma and has received priority designation from the U.S. Secretary of Defense. Although investigational, this effort aims to gather real-world evidence of the HAV's potential benefits.

Humacyte, Inc. (Nasdaq: HUMA) will release its financial results for Q1 2022 on May 13, 2022, followed by a webcast at 8:00 a.m. ET for a corporate update. The company specializes in developing bioengineered human tissues, particularly human acellular vessels (HAVs), which are in late-stage clinical trials for various vascular applications. The HAV has received FDA designations for its significant medical potential, including RMAT and Fast Track status. This webcast will be accessible for 30 days post-event on their website.

Humacyte, Inc. (Nasdaq: HUMA) has appointed Shamik J. Parikh, M.D., as its Chief Medical Officer. Dr. Parikh, who brings over 20 years of experience in clinical development and product launches, will oversee Humacyte's global clinical development strategy. His expertise will be crucial as the company advances its Human Acellular Vessel (HAV) through late-stage clinical trials for vascular applications. CEO Laura Niklason emphasized that Dr. Parikh's background in patient safety and drug strategy will be invaluable in progressing their bioengineered tissue products.